(32 days)
The Dry Laser Imager, DRYPRO Model 832 is intended to be used to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The output image is not a high resolution and DRYPRO Model 832 is not intended for use with FFDM systems.
The Dry Laser Imager, DRYPRO Model 832 is a Laser Imager to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The device consists of film supplying unit, film transferring unit, exposing unit, heat-developing unit, operating unit, power supplying unit and main control unit. This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10. This device has no patient contacting materials and is intended to be used by trained personnel only. The output of the device is evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention in case of malfunction.
This document describes the Konica Minolta Medical & Graphic, Inc. Dry Laser Imager, DRYPRO Model 832, a medical image hardcopy device, seeking 510(k) clearance. The device is intended to receive image data from diagnostic equipment (CT, MRI, DSA) and print it on medical dry-film. It explicitly states that the output image is not high resolution and is not intended for use with FFDM (Full Field Digital Mammography) systems.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a typical quantitative pass/fail format for clinical performance. Instead, it presents a comparison table between the new device (DRYPRO Model 832) and its predicate device (DRYPRO Model 771) to demonstrate substantial equivalence based on technical specifications and intended use. The implicit acceptance criterion is that the new device's performance characteristics are comparable to or improved over the predicate device, or any changes do not raise new questions of safety or effectiveness.
| Item | Predicate Device (DRYPRO Model 771) Reported Performance | New Device (DRYPRO Model 832) Reported Performance |
|---|---|---|
| Laser Source | Laser Diode [LD] (810nm) | Laser Diode [LD] (785nm) |
| Laser Power | 100mW (Maximum Output) | 240mW (Maximum Output) |
| Laser Modulator | Direct driving modulator | Direct driving modulator |
| Film Type | Konica Medical Imaging Film (SD-P & SD-Pc) | Konica Medical Imaging Film (SD-P & SD-Pc) |
| Film Sizes | 14"x 17", 14"x 14", 11"x 14" | 14"x 17", 14"x 14", 11"x 14", 10"x 12", 8"x 10" |
| Film Supply | 1 unit | 1 unit or 2 units (125 or 50 film on each) for installation of Optional Supply |
| Interface | 10/100base-TX, 4 network ports maximum | 10/100/1000base-TX, 4 network ports maximum |
| Protocol | DICOM version 3.0, Print service class | DICOM version 3.0, Print service class |
| Image Data Storage | one Hard Disk Drive | outside PC |
| Image Formatting | 1,2,4,6,9,12,15,16,20,24,25,30,35,36,42, and 48 frame formats, and mixed formats available. | 1,2,4,6,9,12,15,16,20,24,25,30,35,36,42, and 48 frame formats, and mixed formats available. |
| Pixel Size | 78.6 micro-meters minimum | 78.6 micro-meters minimum |
| Density Resolution | 14bits / pixel | 14bits / pixel |
| Cycle Time | 30 sec. | 40 sec. |
| Test Pattern | Pre-programmed SMPTE pattern | Pre-programmed SMPTE pattern |
| Smoothing | Choice of Pixel replication, Bi-linear. Spline functions via network | Choice of Pixel replication, Bi-linear. Spline functions via network |
| Image Rotation | Choice of 0 (normal), 90 degrees via network | Choice of 0 (normal), 90 degrees via network |
| Exposure Setting | 8 types / port via network | 8 types / port via network |
| Image Borders | Choice of black or clear via network | Choice of black or clear via network |
| Image Framing | Choice of framing or no framing via network | Choice of framing or no framing via network |
| Print Developing | Choice between negative and positive printing via network | Choice between negative and positive printing via network |
| Character Input | Data and message data printed in margins via network | Data and message data printed in margins via network |
| Copying | 99 copies per print maximum via network | 99 copies per print maximum via network |
| Controller Display | Backlight liquid-crystal display (20 places, 2 lines) | Backlight liquid-crystal display (20 places, 2 lines) |
| External Dimensions | W630mm x D600mm x H1125mm | W599mm x D585mm x H570mm |
| Weight | Approx. 175Kg | Approx. 95Kg |
| Power Consumption | 1020VA maximum (destination of USA) | 1200VA maximum (destination of USA) |
| Exhaust Heat | Approx. 950kJ / hour | Approx. 1200kJ / hour |
| Purpose of use | The device is intended for the use at the X-ray department of the hospital, etc. the device that will acquire data from diagnostic equipment and then print the data onto laser imaging film. | The device is intended for the use at the X-ray department of the hospital, etc. the device that will acquire data from diagnostic equipment and then print the data onto laser imaging film. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical performance study with a "test set" in the context of an AI/algorithm-driven device for diagnosis. This device is a hardcopy printer. The evaluation for substantial equivalence relies on comparing technical specifications and intended use with a predicate device. Therefore, there's no explicitly defined "sample size" or "data provenance" as would be relevant for an algorithm's diagnostic performance. The testing would have focused on the device's functional performance, image quality, and safety standards, but the details of such internal testing are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As a medical image hardcopy device, the "ground truth" refers to the fidelity and accuracy of the printed image compared to the digital input and established image quality standards for medical prints. There are no mentions of "experts" establishing clinical ground truth for diagnostic purposes in this document, as the device does not perform diagnosis.
4. Adjudication Method for the Test Set
Not applicable for this type of device. Adjudication methods are relevant for evaluating diagnostic accuracy from algorithms or readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This device is a printer, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a hardware device for printing, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this hardcopy device would implicitly refer to the technical specifications of image quality (e.g., pixel size, density resolution, print fidelity) as verified against industry standards (like those in DICOM and potentially SMPTE patterns mentioned). It's about ensuring the printed output accurately represents the digital input according to established technical benchmarks, rather than a clinical ground truth for a diagnostic finding.
8. The Sample Size for the Training Set
Not applicable. This device is a laser imager, a hardware product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.